Blood Glucose Meter - India CDSCO Medical Device Registration

Blood Glucose Meter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000205_0cd899f520408fad46ffc84616a299e6_8a6a85736df73795bdd40e37f1c2cc6a. This device is marketed under the brand name Accu-chek Guide Link meter. The license holder is Roche Diabetes Care India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Blood Glucose Meter

UID: IMP/IVD/2022/000205_0cd899f520408fad46ffc84616a299e6_8a6a85736df73795bdd40e37f1c2cc6a

Brand Name

Accu-chek Guide Link meter

License Holder

Roche Diabetes Care India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Accu-Chek Performa meter is intended to be used for blood glucose selfmonitoring by people with Diabetes. This system is not for use in diagnosis or screening of diabetes mellitus. The Accu-Chek Performa test strips with Accu-Chek Performa meter is intended to quantitatively measure glucose in fresh capillary, venous arterial and neonate whole blood for the finger, palm, forearm, upper arm, as an aid in monitoring the effectiveness of glucose. The AccuChek Performa test strips with Accu-Chek Performa meter is intended in-vitro diagnostic selftesting by people with diabetes. The Accu-Chek Performa test strips with Accu-Chek Performa meter is intended in-vitro diagnostic use by healthcare professional in clinical settings and people with diabetes. The Accu-Chek Performa system is intended to be used by a single PwD and healthcare professional in the clinical healthcare environment as an aid to effective diabetes management